Kornimate/medical-research-clean huggingface dataset:
aribulin combined with carboplatin and bevacizumab in the treatment of ovarian cancer

Conditions: Ovarian Cancer

Summary: this is a prospective phase ii, single-center, single-arm clinical study of platinum-sensitive relapsed ovarian cancer. the main objective of this study is to evaluate the efficacy, safety and tolerability of aribrine combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive relapsed ovarian cancer.

this is a phase ii prospective, single-center, single-arm clinical study for platinum-sensitive recurrent ovarian cancer. the main objective of this study is to evaluate the efficacy, safety and tolerability of alibulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer. trial time plan: the inclusion time of the plan: 22 months. planned trial duration: 24 months. 1. experimental drugs: aribrine mesylate injection, carboplatin, bevacizumab. 2. administration regimen: iribrine mesylate injection: 1.4mg/m2i.v. 30 min, d1 d8, every 21 days; carboplatin: auc=5\~6 i.v. d1, every 21 days; bevacizumab: 7.5mg/kg, i.v. 30-90 min,d1, every 21 days. the dose can be adjusted according to the state of the patient.

Eligibility criteria:
inclusion criteria: * patients with measurable or immeasurable disease (recist v1.1) or ca 125 evaluable disease (gcig criteria) or histologically confirmed diagnosis of recurrent ovarian cancer. * first disease recurrence after first-line platinum chemotherapy \>6 months. * 18 years of age ≤75 years of female. * expected survival ≥ 3 months. exclusion criteria: * partial tumor related symptoms. * partial comorbidity. * subjects developed new secondary malignancies. * other.
opiate free multimodal pain pathway in elective foot and ankle surgery: a prospective study

Conditions: Bunion of Unspecified Foot; Bunionette of Unspecified Foot; Hammertoe; Ankle Fractures; Achilles Tendon Surgery

Summary: orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period, despite the ongoing opioid crisis in the united states. while opioid-free multimodal pathways have shown promising results, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. this study aims to evaluate post-operative pain following the use of an opioid-free pain treatment plan for patients undergoing foot and ankle surgeries.

despite the presence and increased understanding of the opioid crisis in the united states, orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period. in an effort to minimize narcotic analgesia and its potential side effects, opioid-free multimodal pathways have been developed in many orthopaedic sub-specialties with promising results. there have been early studies reporting the results of non-narcotic protocols during the intra-operative period. likewise, there have been several studies reporting the results of inpatient non-narcotic pain protocols in select foot and ankle surgeries. however, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. currently, our practice utilizes an opioid-free post-operative pain protocol for patients undergoing elective outpatient foot and ankle surgery. the goal of this study is to evaluate post-operative pain using this opioid-free multimodal pain protocol at days 1,3, and 8 following elective outpatient foot and ankle surgery.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * outpatient, elective, primary foot and ankle surgery not due to infection including: * bunion or bunionette surgery, hammertoe surgery, ankle fracture, achilles tendon surgery (primary mid-substance repair, haglund's deformity correction with debridement), ankle arthroscopy exclusion criteria: * \<18 years of age * undergoing revision surgery * allergic to more than 1 medication listed in protocol * creatinine clearance \>1.5 * known end-stage renal, stage 2 or higher * history of gi bleed, ulcer, nsaid-induced gastritis, and/or gastric bypass * history of active liver disease or child-pugh class 2 liver failure or above * history of pain syndromes including: fibromyalgia, complex regional pain syndrome/reflex sympathetic dystrophy, hyperalgesia * inability to undergo regional anesthesia due to inability to obtain nerve block, prior nerve damage or anatomy, or anesthesiologic best judgement * currently pregnant
metabolic syndrome criteria and the effect of testosterone treatment in young men with hypogonadism

Conditions: Hypogonadism

Summary: the study is designed to answer the following questions: 1. is hypogonadism a cause for the metabolic syndrome ? 2. what is the effect of testosterone replacement on the metabolic parameters ?

this is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2002-2009.

Eligibility criteria:
inclusion criteria: * men * congenital hypogonadism * treatment naive exclusion criteria: * previous history of androgen replacement * hypertension * diabetes mellitus

Keywords: metabolic syndrome hypogonadism testosterone
hkt-500 in the treatment of adult patients with ankle sprain

Conditions: Ankle Sprain

Summary: the objective of this study is to demonstrate the multiple-dose efficacy and safety of hkt-500 for the treatment of ankle sprain.

a randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of hkt-500 in the treatment of pain associated with mild to moderate ankle sprain

Eligibility criteria:
inclusion criteria: * mild to moderate ankle sprain exclusion criteria: * any women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), who is not at least 2 years postmenopausal, or has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to visit 1.

Keywords: ankle sprain
critical care observation of motor activity (coma) and sicu outcomes

Conditions: Motor Activity; Muscle Strength; Muscle Weakness

Summary: in the surgical intensive care unit (sicu), goals of critical care are often discussed in long-term ventilated patients around the time of extubation. muscle weakness predicts extubation failure but formal muscle strength assessment by the medical research council scale is time-consuming and not part of the daily clinical exam. in this observational study, we hypothesize that coma measurement, routinely used by the sicu nurses, is a reliable and valid predictor for patients' sicu outcomes. this prospective observational study is carried out within a consecutively enrolled cohort of adult patients who are extubated in two sicus at massachusetts general hospital, boston.


Eligibility criteria:
inclusion criteria: * intubated and mechanically ventilated patients in 2 icus at massachusetts general hospital * adult patients exclusion criteria: * tracheostomy without extubation attempt * death without extubation attempt/terminal extubation

Keywords: critical care patient discharge costs and cost analysis length of stay hospital mortality
study to evaluate the effect of cetuximab on corrected qt (qtc) interval changes in patients with advanced malignancies from solid tumors

Conditions: Advanced Cancer

Summary: the purpose of this study is to determine whether corrected qt (qtc) interval changes occur on an electrocardiogram (ecg) when cetuximab is administered to the study population.


Eligibility criteria:
inclusion criteria: * advanced or metastatic malignant disease originating from solid tumors * adequate recovery from previous therapy or intervention; at least 21 days since major surgery or prior radiation therapy * measurable or evaluable disease exclusion criteria: * women of childbearing potential (wocbp) who are breastfeeding, pregnant, or unwilling or unable to use acceptable contraception during the study and for at least 12 weeks after the last on-study dose of cetuximab * men unwilling to use acceptable contraception during the study if engaged in sexual relations with a wocbp * symptomatic brain metastasis * history of myocardial infarction 6 months or less prior to study entry, of severe congestive heart failure, of uncontrolled angina, or of uncontrolled arrhythmias * clinically relevant abnormality on screening electrocardiogram (ecg), preventing an accurate measurement of the qt interval * congenital long qt syndrome * history of risk factors for ventricular tachycardia or torsades de pointes or history of fainting, unexplained loss of consciousness, or convulsions * prolonged qtc interval on screening ecg (greater than 470 msec) using fridericia's correction formula * heart rate slower than 50 bpm or faster than 100 bpm at rest during screening ecg measurements * implantable pacemaker or automatic implantable cardioverter defibrillator * sustained supine systolic blood pressure higher than 150 mmhg or lower than 90 mmhg or a diastolic blood pressure lower than 45 mmhg or higher than 95 mmhg at screening * known history of arterial thrombotic events within 6 months prior to study initiation * known history of significant peripheral artery disease * current participation in a clinical trial with another investigational new drug or device * receipt of an investigational new drug or device within 21 days prior to enrollment in this study
screening of fabry disease in patients with left ventricular hypertrophy detected in echocardiography

Conditions: Left Ventricular Hypertrophy

Summary: the purpose of this study is to determine the prevalence in belgium of fabry disease in patients with unexplained hypertrophic cardiomyopathy measured by echocardiography and to determine in fabry patients which was the most frequently initial symptom. actually the early diagnosis is important because a treatment exists that can prevent future complications.


Eligibility criteria:
inclusion criteria: * unexplained left ventricular hypertrophy exclusion criteria: * isolated septal hypertrophy
does immediate lymphatic reconstruction decrease the risk of lymphedema after axillary lymph node dissection

Conditions: Breast Cancer Lymphedema

Summary: the researchers are doing this study to see if having immediate lymphatic reconstruction after axillary lymph node dissection (alnd) can decrease the development of lymphedema, a side effect of alnd. other purposes of the study include: comparing the approach of immediate lymphatic reconstruction after alnd with the approach of alnd alone looking at whether having immediate lymphatic reconstruction after alnd improves a person's quality of life seeing if adding standard of care radiation therapy to either study approach (immediate lymphatic reconstruction after alnd or alnd alone) has an effect on development of lymphedema


Eligibility criteria:
inclusion criteria: * female breast cancer patients 18-75 years of age * patients consenting for unilateral alnd (prior history of slnbx allowed if \<6 months from consent) or patients consenting for unilateral slnbx with possible alnd, with a clinically or radiographically positive lymph node or a high likelihood of alnd per the breast surgeon * identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of alnd during surgery exclusion criteria: * male breast cancer patients * non-english speaking participants * female breast cancer patients with axillary recurrence * female breast cancer patients who have a history of alnd * female patients requiring bilateral alnd for the treatment of their breast cancer * female breast patients treated with slnbx only

Keywords: axillary lymph node dissection lymphatic reconstruction 20-021
study of the contribution of mutant p53/yap proteins to therapy resistance in recurrent head and neck cancer

Conditions: Head and Neck Tumors

Summary: multicenter, non-interventional, retrospective/prospective study of a biological nature, on patients affected by head and neck tumors, for which the collection and use of tissue samples is planned for the study of the mutational profile, the transcriptional profile and the proteomic profile.

the study aims to characterize molecular networks governed by the mutated protein p53 with a relevant role in the development of local recurrence in head and neck tumors hnscc, in order to identify the main actors involved in resistance to current therapy and try to develop new more effective therapeutic strategies for head and neck tumors. furthermore, the existence of a significant relationship between the time of onset of recurrence and the deregulation of the identified molecular networks will be studied. this study will therefore allow to: 1. identify networks associated with the presence of mutation in the tp53 gene relevant in the development of relapse, comparing the tissues of the primary tumor to the respective tissue of the relapse of patients affected by head and neck cancer, by: 1. expression profiles of coding and non-coding rnas (retrospective cohort) 2. mutational profile by ngs (retrospective cohort) 3. single cell rna-sequencing (sc-rnaseq) on samples belonging to the prospective cohort 2. characterize the molecular mechanisms underlying tp53-dependent networks with a key role in resistance to therapy, using resistance cell systems and in organoid cultures derived from head and neck tumors hnscc (pdo) (prospective cohort). 3. identify the best treatment combinations able to target the networks identified as associated with resistance (prospective cohort). 4. to evaluate the response of treatments in vivo using a syngeneic model of head and neck tumors hnscc (moc model).

Eligibility criteria:
inclusion criteria: * age over 18 * patients with squamous cell tumors of the oral cavity, pharynx or larynx * surgical patients with primary hnscc tumors, who have not had previous tumors in other sites or adjuvant treatments prior to surgery. * availability of adequate material (tissue) for the planned analyses * availability of follow-up data for at least one year (retrospective part) * written informed consent (prospective part and/or, for the retrospective part, traceable patients and/or patients in follow-up and/or if necessary for the legal nature/institutional purposes of the participating centers). exclusion criteria: * presence of distant metastases at the time of diagnosis * previous head and neck cancer * second cancer undergoing treatment or follow-up for less than 5 years

Keywords: head and neck tumors tp53 organoids
adult idiopathic inflammatory myopathy with cardiac injury

Conditions: Inflammatory Myopathy; Cardiac Disease

Summary: adult patients with suspected or confirmed idiopathic inflammatory myopathy (iim) will be recruited. patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and blood taken. the collection of data and biological material will mirror usual clinical practice as far as possible. subjects will ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures recorded and questionnaires completed.in addition, blood, muscle biopsies and imaging undertaken as part of usual care will also be collected for research purposes to measure a number of biomarkers for the assessment of diagnostic accuracy and clinical utility evaluation. as per usual practice, a muscle biopsy will be performed at baseline, and a further biopsy offered at 6 months to assess treatment response. a magnetic resonance (mr) muscle protocol will also be performed as per usual clinical practice, and a gadolinium-enhanced mr heart scan offered. both these scans will be repeated at 6-12 months. an existing electronic database entry system will be used for data entry and capture on an anonymised basis.


Eligibility criteria:
inclusion criteria: * all patients who had a confirmed (muscular biopsy, electromyogram, magnetic resonance imaging) or suspected clinically myositis * age over 18 years old * signature of the informed consent form for the study exclusion criteria: * patients with disease duration \>2 years * patients \< 18 years * confirmed non-inflammatory myopathies * myositis secondary to alcohol or drug abuse * patients unwilling or unable to give consent * patients with poor or no venous access
efficacy of a home-based stretching program on fibromyalgia symptoms: a randomised controlled trial

Conditions: Fibromyalgia; Stretch; Adherence, Treatment

Summary: this randomised controlled trial will examine the clinical efficacy of a six-week, novel, home-based stretching programme compared to usual care on the effect of symptoms experienced by patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * individuals diagnosed with fibromyalgia in accordance with the acr 2016 diagnostic criteria. * individuals diagnosed with chronic non-malignant pain or individuals diagnosed with chronic widespread pain (including fibromyalgia syndrome) are also included when they meet the acr 2016 diagnostic criteria. exclusion criteria: * non-controlled systemic disorders (such as hypertension, diabetes and coronary insufficiency), * neurological conditions that impair alertness or comprehension, musculoskeletal conditions that could compromise assessments (such as nerve root compression or knee joint inflammation), * relevant joint disorders (such as severe arthritis, arthroplasty of the hip or knee, and rheumatoid arthritis), * recent changes in therapy for fibromyalgia (i.e., within four weeks of baseline).

Keywords: fibromyalgia stretching exercises home-based adherence
investigation of specific protein/markers in patients with osteoarthritis of the knee having a total knee replacement

Conditions: Osteoarthritis of the Knee

Summary: the main purpose of the study is to better understand how specific proteins/markers in blood, urine, synovial fluid (a lubricating fluid secreted by the membrane lining the joints), and joint tissue are involved in osteoarthritis of the knee. the aim is to investigate if there is a correlation between x-ray results, specific proteins/markers and different types of pain in patients with osteoarthritis of the knee. the study consists of 3 visits over 3-20 days and the last visit will be the day of surgery.

investigation of biomarkers in an exploratory study in patients with osteoarthritis of the knee undergoing total knee replacement surgery

Eligibility criteria:
inclusion criteria: * patients who will undergo a total knee replacement due to osteoarthritis. * symptoms of the knee for at least 6 months prior to study start. exclusion criteria: * key-hole surgery performed on target knee within 3 months prior to study start. * history of disorders in which part of the immune system is missing or defective.

Keywords: osteoarthritis of the knee biomarkers
mesorectal excision (me) versus me with lateral node dissection for stage ii, iii lower rectal cancer (jcog0212)

Conditions: Rectal Neoplasms

Summary: the purpose of this study is to evaluate the of international standard operation, mesorectal excision (me alone) compared to japanese standard operation, me with lateral lymph node dissection for clinical stage ii, iii lower rectal cancer

total mesorectal excision (tme) or mesorectal excision (me) with lateral lymph node dissection for advanced rectal cancer is widely performed in japan. in other countries, tme or me without lateral lymph node dissection is the standard. in order to determine which is the better rectal cancer surgery, relapse-free survivals of these are compared as the primary endpoint.

Eligibility criteria:
inclusion criteria: preoperative criteria: 1. histologically confirmed adenocarcinoma 2. clinical stage ii or iii 3. preoperative findings: * main lesion of the tumor is located at the rectum * lower tumor margin is below the peritoneal reflection * no extramesorectal lymph node swelling (shorter diameter is less than 10 mm) * no invasion to other organ (s) 4. patient age is more than 20 and less than 75 5. ps: 0, 1 6. no past history of chemotherapy, pelvic surgery or radiation 7. written informed consent operative criteria: 8. mesorectal excision is performed 9. operative findings: * main lesion of the tumor is located at the rectum * lower tumor margin is below the peritoneal reflection 10. r0 after resection exclusion criteria: 1. multiple cancer patients 2. pregnant patients 3. psychological disorder 4. steroid administration 5. cardiac infarction within six months 6. severe pulmonary emphysema and pulmonary fibrosis 7. doctor's decision for exclusion

Keywords: rectal cancer lymph node dissection rectal surgery autonomic nerves stage ii, iii lower rectal cancer
hhv8 and solid organ transplantation

Conditions: HHV8; HHV8 Infection; HHV8-Related Malignant Neoplasm; Kaposi Sarcoma; Lung Transplant; Complications; Liver Transplant; Complications; Kidney Transplant; Complications; Castleman Disease

Summary: solid organ transplant candidates will undergo serological screening for hhv8 at time of listing and transplantation. in the event of a recipient/donor mismatch r-/d+ or in the presence of a seropositive recipient (r+), blood levels of hhv8 dna will be monitored together with specific igra for hhv8.

patients on the waiting list for solid organ transplantation will undergo serological screening for hhv8 (lytic and latent antigens) in the pre-transplant phase, both at time of listing and then at the time of transplantation; if seropositivity is found, further investigations will be performed, i.e. blood levels of hhv8 dna and specific elispot for hhv8. as for donors, serological testing for hhv8 (lytic and latent antigens) will be performed. after solid organ transplantation * patients found hhv8 seropositive in the pretransplant phase (r +), being at risk of hhv8 reactivation, will be monitored monthly in terms of viremia (hhv8 dna) and specific igra for hhv8 for the first 6 months after transplantation and subsequently every 3 months up to 12 months post transplant. * in case of patients who were found hhv8 seronegative at time of transplantation, donor serology will be evaluated. in case of r-/d+ mismatch, sot recipients will receive the same monitoring of r + patients (blood levels of hhv8 dna and specific igra for hhv8 monthly for the first 6 months and then every 3 months up to 12 months after transplantation). * with reference to lung transplant patients, in cases of r + or r- / d +, hhv8 dna will also be searched on the bal obtained during surveillance bronchoscopies (usually at 3, 6 and 12 months after transplantation).

Eligibility criteria:
sot donors: inclusion criteria: * all donors used for transplantation purposes (kidney, liver, lung), including living donors in case of kidney transplantation exclusion criteria: * none sot candidates recipients: inclusion criteria: * all patients listed for solid organ transplantation (lung, liver and kidney) exclusion criteria: * none

Keywords: hhv8 solid organ transplant lung transplant liver transplant kidney transplant kaposi sarcoma castleman disease